For the purposes of clarity, when interpreting the disclosure contained in this document, several terms will be defined before their use. When used herein “sexual assault” is to be interpreted broadly in order to encompass rape and sexual assault as defined by the Bureau of Justice Statistics whose definitions are to follow. According to the Bureau of Justice Statistics, “rape” is defined as “[f]orced sexual intercourse including both psychological coercion as well as physical force. Forced sexual intercourse means penetration by the offender(s). Includes attempted rapes, male as well as female victims, and both heterosexual and homosexual rape”; and “sexual assault” is defined as “[a] wide range of victimizations, separate from rape or attempted rape. These crimes include attacks or attempted attacks generally involving unwanted sexual contact between victim and offender”. This definition of sexual assault as it is used in the disclosure made herein should be considered to further include any of the aforementioned events perpetrated against gay, bisexual, lesbian, transgendered, and questioning (GBLTQ) individuals. The term “evidence”, when used herein, should be interpreted so as to include any material that may provide for specimens that may potentially contain either DNA or other information that may be pertinent to a controversy. The term “degradation”, as used in this disclosure, should be interpreted as any loss of integrity or quality. Additionally, for the purposes of interpreting the disclosure made herein, the terms “component” and “module”, or derivations thereof, as well as “sample” and “specimen”, or derivations thereof, are used interchangeably and should be considered synonymous.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure, and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
Specimens, including those that may include DNA, may be retrieved from one or more of any number of areas including, but not limited to, body cavities for some time following their deposition or exchange, and from environments with non-biological chemical elements, including but not limited to areas outside the body. Specimens containing DNA obtained immediately after, or proximate to, an incident stand the highest chances of producing meaningful results; however, despite this, specimens obtained up to one week after their deposition still may have up to approximately an 80% chance of producing a positive result for present DNA using state of the art analysis technology (e.g. enhanced Y-chromosome short tandem repeat (Y-STR) analysis, etc.). The chances of successful collection of viable DNA from these specimens decline at a rate of approximately 20% for each week that passes between specimen deposition and collection. As a result of continuing improvements in DNA analysis, it is possible that specimens obtained even 4 weeks following an incident still have a 20% chance of yielding viable DNA that could be analyzed in order to yield a DNA profile.
Locard's principle holds that the perpetrator of a crime will bring something into the crime scene and leave with something from it, and that any materials exchanged in such a manner may be used as forensic evidence. Should bodily fluids containing DNA of the perpetrator be deposited in, on, and/or near a victim, to increase the likelihood that authorities may identify a perpetrator, evidence should be collected in a timely fashion without dilution or contamination. Furthermore, the collected specimen must remain non-diluted and contaminant-free, while maintained and handled within a regimented, identifiable, and documented chain of custody (CoC) until analysis, in accordance with standard operating procedure (SOP), may be completed. The device(s) used to collect all relevant specimen(s) may additionally comport with current and forthcoming Unique Device Identification (UDI) regulations as defined by the United States Food and Drug Administration (FDA).
Few people who are victims of sexual assault possess the training to successfully collect a specimen from their own body that could potentially contain a sexual assault perpetrator's DNA. Additionally, even if a victim of a sexual assault knows how to collect a specimen that may contain DNA, it is unlikely that they will have immediate access to tools for specimen collection and preservation at, or immediately following, the time of the assault. Furthermore, devices currently employed in the art are not constructed for self-collection by the victim, but rather for use by a qualified, trained medical professional in a setting that has specialized exam tables and other apparatus. This, combined with the awkward ergonomics of these devices in the self-collection context, make self-collection of such specimens difficult, if not impossible.
Frequently, a specimen becomes contaminated through the collection process itself, rendering that evidence of little to no use. Contamination may obscure or obliterate a perpetrator's potential identification. Specimens may become contaminated, diluted, or suffer degradation despite being collected in a timely and skillful manner if the specimen is not transported, handled, stored, and analyzed effectively.
Packaging, handling, transportation, and/or storage of collected specimens are usually necessary before the collected specimen can be tested, examined, and otherwise analyzed in accordance with SOPs. During packaging, handling, transportation, handling, and/or storage, collected specimens may suffer contamination, dilution, or degradation, even if the collected specimens had been properly collected. In court cases where DNA evidence is being introduced, improper or procedurally proper but ineffective methods of storing the DNA evidence may be introduced to challenge the validity of the evidence and/or the associated test results. There are several ways that these can be challenged: a) the methods not being properly followed, b) the results not being properly applied, or c) the current method itself being ineffective. Therefore, it is important to have collected specimens retained in such a manner consistent with standardized policies and procedures for analysis so as to best preserve specimens until such time as described in analysis and storage policies and procedures.